Implementation of Modified Q-Control Chart in Monitoring of Inspection Characteristics with Finite Quantification Sensitivity Limits: A Case Study of Bioburden Enumeration in Capsule Shell

Application of statistical process control (SPC) methodologies has become increasingly crucial in various business fields to control, monitor and improve processes, addition the support management decision-making. However, many inspection characteristics have limited quantification limits beyond which results are reported as either “ higher than” such testing microbiological burden healthcare products after definite dilution level ex. 1:10, 1:50 or 1:100. The present case study demonstrated application combined quality score trending chart concept with Laney-modified attribute process-behavior for monitoring bioburden successive deliveries empty hard gelatin capsule. Microbiological database was segmented into intervals based on both specification minimum sensitivity limit Total Viable Aerobic Count (TVAC) Yeast Mold (TYMC). Each segment assigned a starting low value threshold. Preliminary investigation dataset pattern showed that record did not follow any presumed distribution construction ordinary chart. Data right (positively) skewed no apparent tendency Poisson, binomial normal distribution. Laney-Quality contents CFUs ranks aberrant spotted.